Valneva: new positive data in Lyme disease
(CercleFinance.com) - Valneva and Pfizer announce positive immunogenicity and safety data from the phase 2 VLA15-221 study, following a second booster vaccination with its Lyme disease vaccine candidate, VLA15, one year after the first booster dose.
The immune response and safety profile one month after this second booster dose were similar to those reported after the first, demonstrating the potential benefit of a booster vaccination before each Lyme disease season.
There is currently no human vaccine against Lyme disease, and VLA15 is the most advanced vaccine candidate against this disease, with two Phase 3 trials underway, the two healthcare groups highlighted.
Pfizer aims to submit marketing authorization applications to the US FDA and the European Medicines Agency in 2026, provided the Phase 3 data obtained are positive.
The US Centers for Disease Control and Prevention (CDC) estimates that approximately 476,000 people are diagnosed and treated for Lyme disease each year in the US, and 129,000 cases are reported annually in Europe.
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The immune response and safety profile one month after this second booster dose were similar to those reported after the first, demonstrating the potential benefit of a booster vaccination before each Lyme disease season.
There is currently no human vaccine against Lyme disease, and VLA15 is the most advanced vaccine candidate against this disease, with two Phase 3 trials underway, the two healthcare groups highlighted.
Pfizer aims to submit marketing authorization applications to the US FDA and the European Medicines Agency in 2026, provided the Phase 3 data obtained are positive.
The US Centers for Disease Control and Prevention (CDC) estimates that approximately 476,000 people are diagnosed and treated for Lyme disease each year in the US, and 129,000 cases are reported annually in Europe.
Copyright (c) 2024 CercleFinance.com. All rights reserved.